Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children (MeloDex)

• ClinicalTrials.gov Identifier: NCT04665453
• Recruitment Status: Recruiting
• First Posted: December 11, 2020
• Last Update Posted: December 16, 2020
• Sponsor: University Medical Centre Ljubljana
• Information provided by (Responsible Party): Damjan Osredkar, University Medical Centre Ljubljana

Study Description

Brief Summary:

The aim of the study is to compare the effect of melatonin, given orally, dexmedetomidine, given intranasally, and dexmedetomidine given sublingually on sleep induction, sleep duration, their possible impact on vital functions and technical implementation of EEG.

Condition or disease	Intervention/treatment	Phase
Electroencephalography; Child; Dexmedetomidine; Melatonin; Sleep; Epilepsy	Diagnostic Test: Electroencephalography; Diagnostic Test: Monitoring of vital functions; Drug: Melatonin 0,1mg/kg oral syrup; Drug: Dexmedetomidine 3 mcg/kg sublingually; Drug: Dexmedetomidine 3 mcg/kg intranasally	Not Applicable

Detailed Description:

At University Medical Centre Ljubljana (UMCL; Slovenia), the investigators use electroencephalography (EEG) in wakefulness and sleep for diagnostic and therapeutic purposes in children with (suspected) epilepsy. Since epileptiform activity can only be detected during sleep in some patients and because children with intellectual disabilities have sometimes problems with cooperation, EEG in induced sleep is required.

In this study, the investigators will enroll 150 children who need EEG recorded in their sleep. The investigators will compare safety and efficacy of the two active substances, one of which will be given in two possible routes. Fifty children will receive melatonin in the form of a syrup orally, 50 children will receive dexmedetomidine intranasally in the form of a nasal spray, and 50 children will receive dexmedetomidine sublingually. The investigators will monitor the following parameters: the time in which the child falls asleep, vital functions during sleep (blood pressure, blood oxygen saturation, respiratory rate frequency and heart rate frequency), the impact on the technical implementation of EEG, the depth of sleep and waking time. All parents will give their written consent for their child to participate in the study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Efficacy of Dexmedetomidine and Melatonin for Sleep Induction for Electroencephalography in Children
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Melatonin peroral; 0,1mg/kg melatonin will be given in the form of a syrup to the participant before EEG and vital functions monitoring	Diagnostic Test: Electroencephalography; Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated; Other Name: EEG; Diagnostic Test: Monitoring of vital functions; Measuring of respiratory rate, heart rate, SpO2, every 10 minutes after the medicine is given to the patient for the duration of EEG, and after 120 minutes. Blood pressure is measured at the time of application of the medicine, at the end of EEG and after 120 minutes.; Drug: Melatonin 0,1mg/kg oral syrup; Melatonine in the form of syrup will be given orally to child.
Experimental: Dexmedetomidine intranasally; 3 mcg/kg of dexmedetomidine in the form of a nasal spray will be given to the participant before EEG and vital functions monitoring	Diagnostic Test: Electroencephalography; Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated; Other Name: EEG; Diagnostic Test: Monitoring of vital functions; Measuring of respiratory rate, heart rate, SpO2, every 10 minutes after the medicine is given to the patient for the duration of EEG, and after 120 minutes. Blood pressure is measured at the time of application of the medicine, at the end of EEG and after 120 minutes.; Drug: Dexmedetomidine 3 mcg/kg intranasally; Dexmedetomidine in the form of nasal spray will be given to child intranasally.
Experimental: Dexmedetomidine sublingually; 3 mcg/kg of dexmedetomidine will be given to the participant sublingually before EEG and vital functions monitoring	Diagnostic Test: Electroencephalography; Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated; Other Name: EEG; Diagnostic Test: Monitoring of vital functions; Measuring of respiratory rate, heart rate, SpO2, every 10 minutes after the medicine is given to the patient for the duration of EEG, and after 120 minutes. Blood pressure is measured at the time of application of the medicine, at the end of EEG and after 120 minutes.; Drug: Dexmedetomidine 3 mcg/kg sublingually; Dexmedetomidine in the form of a solution will be given to child sublingually.

Outcome Measures

Primary Outcome Measures :

1. Comparison of the three medical interventions on sleep initiation [ Time Frame: During the intervention ]
   The time-interval between the drug application and time of sleep initiation will be recorded in minutes. These values will be compared across the three arms of the study
2. Comparison of the three medical interventions on the depth of sleep and the most prominent sleep stage on EEG [ Time Frame: During the intervention ]
   During EEG in sleep, which will be recorderd using a standard 10-20 placement with additional electrodes for breathing and ECG, the EEG background activity will be evaluated for the deepest sleep stage according to the standard EEG classification (Carskadon MA, Dement WC. Normal Human Sleep: an Overview. In: Kryger M, Roth T, Dement WC. Principles and practice of sleep medicine. St.Louis: Saunders/Elsevier, 2011:16-26.). Also, the sleep stage in which the patient will spend the most time will be noted. These values will be compared across the three arms of the study.

Secondary Outcome Measures :

1. Comparison of the three medical interventions on respiratory rate [ Time Frame: During the intervention ]
   Measurement of respiratory rate every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study.
2. Comparison of the three medical interventions on heart rate [ Time Frame: During the intervention ]
   Measurement of heart rate every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study.
3. Comparison of the three medical interventions on oxygene saturation [ Time Frame: During the intervention ]
   Measurement of oxygene saturation using pulse oximetry every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study.
4. Comparison of the three medical interventions on blood pressure [ Time Frame: During the intervention ]
   Measurement of systolic and diastolic blood pressure will be noted at the time of application of the medicine, at the end of EEG and after 120 minutes. These values will be compared across the three arms of the study.

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 20 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age between 1 and 20 years
• Referral for EEG in sleep
• Children/young adults whose parents/caregivers were informed about the aims of the study and have signed the Informed consent form

Exclusion Criteria:

• Children that were unable to follow the study protocol were excluded during the study

Contacts and Locations

Contacts

Contact: Damjan Osredkar, MD, PhD; 0038615229273; damjan.osredkar@kclj.si

Contact: Urška Mahne, MD, BVetMed; 0038615229273; urskamahne@yahoo.co.uk

Locations

Slovenia

University Medical Centre Ljubljana; Recruiting

Ljubljana, Slovenia, 1000

Contact: Damjan Osredkar, MD, PhD damjan.osredkar@kclj.si

Contact: Urška Mahne, MD, BVetMed. urskamahne@yahoo.co.uk

Sub-Investigator: Urška Mahne, MD, BVetMed

Sub-Investigator: Eva Vrščaj, MD

Sub-Investigator: Katja Peganc, OT

Sub-Investigator: David Neubauer, MD, PhD

Sub-Investigator: Mirjana Perković Benedik, MD, PhD

Sub-Investigator: Neli Bizjak, MD, PhD

Sub-Investigator: Zvonka Rener Primec, MD, PhD

Sub-Investigator: Jasna Oražem, MD

Sub-Investigator: Tita Butenko, MD

Sub-Investigator: Nataša Šuštar, MD

Principal Investigator: Damjan Osredkar, MD, PhD

Sub-Investigator: Eva Rihar, MD

Sponsors and Collaborators

University Medical Centre Ljubljana

More Information

• Responsible Party: Damjan Osredkar, Assoc. Prof. Damjan Osredkar, MD, PhD, University Medical Centre Ljubljana
• ClinicalTrials.gov Identifier: NCT04665453
• Other Study ID Numbers: 0120-597/2019/16
• First Posted: December 11, 2020
• Last Update Posted: December 16, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Damjan Osredkar, University Medical Centre Ljubljana:

Child; Dexmedetomidine; Melatonin; Electroencephalography; Autism Spectrum Disorder; Developmental Delay Disorder; Epilepsy; Sleep; Sleep induction

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dexmedetomidine; Melatonin; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antioxidants; Protective Agents